Safety and Efficacy Study of Ambrisentan in Subjects With Pulmonary Hypertension - Full Text View

Sponsor:	Gilead Sciences
Information provided by:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT00380068

Purpose

The primary objective of this study is to evaluate the safety and efficacy of ambrisentan in a broad population of subjects with pulmonary hypertension. Secondary objectives of this study are to evaluate the effects of ambrisentan on other clinical measures of PAH, long-term treatment success, and survival.

Condition	Intervention	Phase
Pulmonary Hypertension	Drug: Ambrisentan	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	ARIES-3: A Phase 3, Long-Term, Open-Label, Multicenter Safety and Efficacy Study of Ambrisentan in Subjects With Pulmonary Hypertension

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension

Drug Information available for: Ambrisentan

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:

The primary endpoint of this study is the change from baseline in 6MWD. [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

A change from baseline in: WHO functional class, SF-36 health survey, Borg dyspnea index, B-type natriuretic peptide (BNP) [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
Monotherapy treatment status [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
Failure-free treatment status [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
Long-term survival [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
Worsening of pulmonary hypertension. [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	August 2006
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Oral tablets taken once daily.

Detailed Description:

This study will enroll up to 200 subjects with PAH and in PH subgroups including PH associated with interstitial lung disease (ILD); PH due to chronic thromboembolic disease or sickle cell disease; PH associated with chronic obstructive pulmonary disease (COPD); PAH associated with congenital heart defects; and PAH associated with HIV. Subjects may be receiving prostacyclin or sildenafil therapy at baseline, and subjects who previously discontinued either bosentan, sitaxsentan, or both, due to liver function test abnormalities are eligible.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Summarized Inclusion Criteria:

18 years of age or older
Current diagnosis of PH associated with an acceptable etiology as outlined in the protocol, including: IPAH, FPAH, PH associated with ILD, PH due to chronic thromboembolic disease or sickle cell disease, PH associated with COPD, and APAH secondary to the scleroderma spectrum of disease, systemic lupus, erythematosus, anorexigen use, congenital heart defects, or HIV infection
Stable regimen (within four weeks) of chronic prostanoid, PDE-5 inhibitor, calcium channel blocker, or HMG-CoA reductase inhibitor therapy
Right heart catheterization completed prior to screening must meet pre-specified criteria
Female subjects of childbearing potential must have a negative serum pregnancy test and must agree to use a reliable double method of contraception until study completion and for at least four weeks following their final study visit.
Male subjects must be informed of the potential risks of testicular tubular atrophy and infertility associated with taking ambrisentan and queried regarding his understanding of the potential risks as described in the Informed Consent Form.

Summarized Exclusion Criteria:

Participation in a previous clinical study with ambrisentan
Bosentan or sitaxsentan use within four weeks prior to the screening visit
AST or ALT lab value that is greater than 1.5 times the upper limit of normal at the screening visit
Pulmonary function tests not meeting pre-specified criteria
Contraindication to treatment with ERA

5. History of malignancies other than basal cell carcinoma of the skin or in situ carcinoma of the cervix within the past five years 6. Female subject who is pregnant or breastfeeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00380068

Hide Study Locations

Locations

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Arizona Pulmonary Specialist, Ltd
Phoenix, Arizona, United States, 85013
United States, California
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, United States, 90502
UCSD Medical Center
La Jolla, California, United States, 92037
West Los Angeles HealthCare Center
Los Angeles, California, United States, 90073
United States, Colorado
University of Colorado Health Science Center
Denver, Colorado, United States, 80262
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
United States, Florida
Mount Sinai Medical Center of Florida, Inc
Miami Beach, Florida, United States, 33140
Suncoast Lung Center
Sarasota, Florida, United States, 34233
United States, Georgia
Atlanta Institute for Medical Research, Inc.
Decatur, Georgia, United States, 30030
Medical College of Georgia
Augusta, Georgia, United States, 30912
United States, Illinois
University of Chicago Hospitals
Chicago, Illinois, United States, 60637
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Maryland
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Boston University Medical Center
Boston, Massachusetts, United States, 02118
BACH Cardiology
Boston, Massachusetts, United States, 02115
Tufts-New England Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University in St. Louis
St. Louis, Missouri, United States, 63110-1093
United States, New Jersey
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
UMDNJ Scleroderma Program
New Brunswick, New Jersey, United States, 08903
University of Medicine & Dentistry New Jersey
Newark, New Jersey, United States, 07103
United States, New York
New York Presbyterian Hospital
New York, New York, United States, 10032
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
The Lindner Clinical Trial Center
Cincinnati, Ohio, United States, 45219
University of Cincinnati - College of Medicine
Cincinnati, Ohio, United States, 45267
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
United States, Oregon
Legacy Clinical Research & Technology Center
Portland, Oregon, United States, 97232
United States, Pennsylvania
University of Pittsburgh Medical Center Presbyterian
Pittsburgh, Pennsylvania, United States, 15213
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Lexington Pulmonary and Critical Care
Lexington, South Carolina, United States, 29072
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
UTHSC-SA
San Antonio, Texas, United States, 78229
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Australia
Royal Perth Hospital
Perth, Australia, 6000
Australia, New South Wales
St. Vincent's Hospital
Darlinghurst, New South Wales, Australia, 2010
Canada, Alberta
Peter Lougheed Center
Calgary, Alberta, Canada, T1Y 6J4
University of Alberta Hospitals
Edmonton, Alberta, Canada, T6G 2B7
Canada, Ontario
London Health Sciences Centre, Victoria Hospital
London, Ontario, Canada, N6A 4W9
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2

Sponsors and Collaborators

Gilead Sciences

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Gilead Sciences, Inc. ( Kathleen DeHaven, Clinical Program Manager )
Study ID Numbers:	AMB-323, ARIES-3
Study First Received:	September 21, 2006
Last Updated:	May 27, 2009
ClinicalTrials.gov Identifier:	NCT00380068 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases

Vascular Diseases
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on November 22, 2009